BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM

    MDR report key: 3080883 · Received April 26, 2013

    Report

    Report Number
    8030965-2013-11140
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    November 16, 2011
    Report Date
    November 16, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K113364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE SCREW SHAFT IS STILL IMPLANTED AND THE HEAD WAS DISCARDED BY THE CUSTOMER. NO PRODUCT WILL BE RETURNED. THE SCREW IS MADE FROM IMPLANT GRADE MATERIAL SO THERE IS NO INCREASE IN RISK WITH LEAVING THE SCREW SHAFT IMPLANTED. NO PRODUCT WAS RETURNED SO NO EVALUATION COULD BE COMPLETED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WRIST FUSION PROCEDURE, THE SURGEON WAS PLACING LCP PLATE AND THE DRILL BECAME LOOSE. THIS OCCURRED WHILE THE SURGEON WAS INSERTING THE LOCKING SCREW. SURGEON CONTINUED TO DRILL AND WAS ABLE TO INSERT THE SCREW, HE TORQUED IT GOOD AND THE SCREW WENT DOWN WITH NO PROBLEM. SURGEON DID NOT LIKE THE POSITIONING OF THE PLATE. HE TRIED BACKING THE SCREW OUT BY USING A SCREWDRIVER BUT IT WAS NOT COMING OUT EASILY. HE USED A NEEDLE NOSE PLIER AND THE HEAD OF THE SCREW CAME OFF. HE WAS ABLE TO REMOVE THE PLATE. SURGEON TRIED REMOVING THE SHAFT OUT WITH PLIERS BUT WAS UNABLE TO. SURGEON FELT THE SCREW WAS DEEP ENOUGH AND LEFT SHAFT IN PATIENT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM. SCREW SHAFT REMAINS IN PATIENT, NOTHING TO RETRIEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182490 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR